Preparing for an ISO 13485 audit

Being the current standard for medical devices; the ISO 13485 prescribes a set of standards that are to be implemented by manufacturers of medical devices. The aim of ISO 13485 is to ensure that medical devices meet the prescribed quality standards. This standard was conceived with the intention of making medical device manufacturers understand ways by which to establish a medical device risk management process.

Implementation needs proper training

Implementation of the ISO 13485 needs expert knowledge. Medical device organizations that need to implement it need to have trained staff, which needs to be aware of what to do when they are approached by an auditor. They should also know what documentation must be completed, kept up-to-date, and be made available, so that the organization can avoid major and minor findings. In addition, they should also be thoroughly aware of the issues that auditors constantly look for. They need to also be knowledgeable about the new updated standard.

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Get trained on how to prepare

To make medical device professionals that face an ISO audit familiar with the dynamics of an ISO audit and to acquaint them with what it takes to be prepared for one when it happens, GlobalCompliancePanel, a globally known provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day, in person seminar.

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To enroll for this seminar and to get a thorough understanding of the ways by which to implement ISO 13485, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900708.

The Director at this seminar, Jason Teliszczak, who is CEO/Founder, JT Environmental Consulting, will give a complete understanding of how to prepare for an ISO audit in a manner that helps organizations defend their actions with the auditors and to avoid a number of errors and goof-ups that could result in harsh actions. In taking a detailed look at each section of the standard; Jason will let participants understand the core elements of an ISO audit.

He will offer real world examples of what to expect, and what to prepare and repeal within the audit guidelines, the ways of ensuring a compliant documentation system, infrastructure maintenance, PPE, ensuring quality by the judicious use of materials, ways of choosing suppliers and vendors, ways of going about an internal audit, and the role of management in certification.

Assessment-based prediction is the basis to good candidate hiring

Hiring is among the most important activities for an organization, because it is the process by which the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with which to make predictions about a potential hire. These questions could relate to how well the resource can perform in the assigned role, for how long the resource could stay in the organization, and making an assessment about the person’s ability to handle more responsibilities.

Not all HR and other hiring managers could be right all the time in predicting the outcomes of their actions about a candidate; yet, a good understanding of principles of assessing the candidate, combined with proper preparation and inculcation of a little disciple will go a long way in helping them become more accurate in their predictions. When the hiring managers are not too way off their mark in predicting the attributes of a useful hire, they are more likely to get a better candidate and avoid much of the unpleasantness that a bad hire can cause.

Learn the art of predicting the usefulness and relevance of a candidate

It is to equip participants with the tools needed to design a process for selecting and promoting for any position across any industry that a two-day, in person seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. This seminar’s Director is Harry Brull, who is President, Laurdan Associates, Inc. and Co-Founder of BCG Consulting Group.recruiter

To get an understanding of how to get the right insight into a selection process that is relatively error-free and effective, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900715.

Insights into getting the hiring and promoting process right

At this seminar, Harry will explore the use of standardized instruments in designing and using simulations for maximizing return on references. This is in addition to the most often-used selection tool, the pre-employment interview.

He will also discuss other important areas of the hiring process, like defensibility and avoiding complaints from unsuccessful applicants, ways of judging a candidate’s interpersonal skills, other capabilities and motivators, and other factors which determine whether there is a good fit between the individual, the position, and the organization.

In addition, Harry will also look at adding other selection tools such as testing and simulations (job samples) to the selection tool mix, which can greatly improve prediction accuracy and provide an alternative view of candidate skills, and techniques which improve the usefulness of reference information, including eliciting vital information from sometimes reluctant sources.

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed.

There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner, coming with adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

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Guidelines lack clarity

However, the challenge that this position presents is that the guidelines –which also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will impart understanding on all these grey areas of human subjects. It will clarify on these regulations.

The Director of this seminar is the highly regarded expert on the subject, Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine. Sarah has developed a comprehensive education program for human subject research which has served as a model for other institutions. To enroll for this highly educative session, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900669SEMINAR?human-subjects-research-seminar-San-Diego-CA.

Ways of applying concepts and theories

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

The speaker will not only provide a refresher of the regulations; she will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participant signing an outdated consent document, etc.) when conducting human subjects.

Outcomes of the seminar

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

Maximizing profits and patient outcomes during times of dwindling reimbursements

Shrinking professional services reimbursements from all insurance companies is a fact that all practices are facing. With patient footfalls falling and operating costs skyrocketing; there is a need for everyone to look at ways by which to generate additional revenue opportunities with their existing patient base and at the same time, maximize patient clinical outcomes.

There exist methods by which all these goals can be achieved. The ways of doing this will be the subject of a two-day seminar that is being organized by GlobalCompliancePanel, a well-known provider of professional trainings for all the areas of regulatory compliance. Gregory J. Simms, President and CEO of DME Advanta, LLC., will be the Director at this seminar. Just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900625SEMINAR to enroll for this  seminar.

Look for the DME option

Simms will demonstrate very practical and simple ways of maximizing revenue and profit to participants from their practice and ways of offering better service outcomes for their patients from their existing patient base. A very important learning he will offer is the ways to set up a Durable Medical Equipment (DME) Revenue Program, which will unlock the keys to financial success in the range of $5,000-$25,000 profit per doctor per month, all with a limited number of patients, and while at the same time staying legally compliant.

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Practitioners for years have been referring the business to O&P shops, manufacturers or 3rd parties because they have all along believed that it is illegal and not profitable. If done following proper guidelines and regulations with appropriate protocols and processes, these can be developed into a full-fledged, profitable program that greatly enhances the value they provide to their patients, as well as their own practices.

A comprehensive set of materials

Apart from explaining the ways of doing this, Director Simms will provide participants with the following critical information and materials at this seminar:

  • How to develop Profits $5,000-$20,000+ per month, per doctor though DME (with but a few patients a week or day)
  • How to become immediate positive cash-flow
  • How to provide a “Convenient One-Stop Medical Shopping” for patients
  • How to maximize “Clinical Outcomes”
  • How to acquire a Medicare DME PTAN license
  • How to become fully accredited and treat numerous practices patients
  • Surgical & non-surgical protocols
  • Criteria to prove medical necessity with formulated SOAP Notes and diagnosis codes
  • Legal Compliance program that addresses all federal & state guidelines
  • The keys to dealing with private insurances, Workers Compensation cases and Personal Injury cases
  • Audits and how to proactively prepare so you never need to worry

He will cover the following areas at this seminar:

  • Return on Investments (Strategic & Financial)
  • Medicare & Accreditation
  • Policies & Processes
  • Executing a Legal Compliance Program

Medical products need to be validated for Radiation Sterilization

Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions.

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To get this right, one simple line of thinking is crucial for medical device manufacturers to inculcate: To “think like a molecule”. This is the basis on which to plan and design around radiation induced changes in the qualities such as color, odor and brittleness that go into the materials.

Learning the right method

Professionals in the medical devices industry, who work on these aspects will benefit immensely from a two-day seminar on the topic, “Validating Radiation Sterilization for Medical Products”, which is being organized by GlobalCompliancePanel, a highly popular provider of professional trainings for all areas of regulatory compliance.

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The Director of this seminar, Karl J. Hemmerich, President of Ageless Processing Technologies, who brings over 35 years of experience in medical device product design, development, manufacturing, and sterilization, will offer a range of learning on this topic.

Identifying the best suited materials

Apart from helping participants identifying the materials that perform best upon radiation, keeping color and odor out of their irradiated products and enhancing product and packaging designs to take advantage of radiation; he will also offer understanding to them on how to avoid the materials that are certain to fail.

This seminar, for which medical device professionals can enroll by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900685SEMINAR?validating-radiation-Washington-DC, has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Understanding optimum sterilization modality

Participants will also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics and understand which modality (Gamma, E-beam, or X-ray) will perform best for their product.

Karl will cover the areas relating to validation of radiation sterilization for medical products, such as Materials Guidances – AAMI TIR # 17, ASTM, sterilization validation and bioburden, Shelf Life Test Methods – Accelerated Aging design, Test Design, Product Design, the influences of product assembly (molding, automation, etc.), material selection and post irradiation degradation, Regulatory Guidances – AAMI/ISO 11137, TIR #17, packaging design and materials, and biological polymers – tissue, serum at this two-day in person seminar.

The following areas will be covered at this seminar:

  • Polymers Chemistry – choosing the best polymer candidate
  • Gamma, E-beam, X-ray sterilization
  • Accelerated Aging
  • Product Qualification
  • Sterilization Validation – Establishing the Minimum Sterilization dose (VDmax)
  • Sterilization Modality Selection Criteria
  • Biocompatibility
  • Preventing Plastic Part Failure Post Irradiation

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance with 21 CFR 820.30 Design Controls. The FDA provides guidance on these.

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Needed: A thorough understanding of these aspects and the FDA’s latest proposed changes

In accordance with the concern evinced by many industry groups and associations, the FDA introduced as many as 60 proposals in August 2010, into the manner in which the 510 (K) process could be expedited. This was done with the intention of accelerating the speed at which newly approved medical devices could be made available to patients across the country. However, with the number of proposals being too many and their scope being too wide; the medical industry suggested that the FDA select for implementation only those proposals that enjoyed the broad consensus of the stakeholders, such as increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions.

An upcoming seminar by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance industries, will clarify on these areas taken up for immediate change by the FDA and place them in the right context. It will address key resources when making critical decisions. This seminar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

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To enroll for this seminar, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900525SEMINAR?bullet-proof-510(k)-Seattle-WA

The Director at this seminar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant. David provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

An understanding of the core elements of the PMA

At this seminar, David will help participants understand how medical device manufacturers can locate a “predicate” device and go through the content and format of the 510(K), and offer an understanding of the De Novo process and the expectations for possibly marketing a low risk device, and the potential impact of FDA’s proposed changes to the 510(K) process and why manufacturers need to pay attention to these.

He will also offer understanding of all the crucial aspects of the PMA, such as the differences between the Traditional, Special and Abbreviated submissions, an understanding of the Substantial Equivalence and how it is applied, who is required to submit the application to FDA, where to submit the 510(K) and what to expect with the review and approval process, when a device company requires this process and when it does not, the applicable exemptions to the submission process and special considerations, and so on.

Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees, who are the organization’s most important resource. It is through an HR audit that an organization evaluates its employees’ strengths and weaknesses.

HR audits help organizations in a number of ways

HR auditing helps organizations in many ways. Through HR audits, organizations are able to ascertain potential and actual problem areas, assess the effectiveness of current HR management activities, measure the weaknesses in HR internal control processes, evaluate human capital strategic and compliance related risks, and suggest corrective action on all these.

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Getting the HR auditing right

The fulcrum for all these for an organization is in getting its HR audit right. The ways by which this can be achieved will be the subject of a seminar that GlobalCompliancePanel, a renowned provider of professional trainings in the regulatory compliance areas, will be organizing. More on this teaching session can be had from

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900673SEMINAR?HR-auditing-identifying-Salt-Lake-City-UT

The Director at this seminar, Ronald Adler, who is President of Laurdan associates, Inc., will offer insights into HR auditing in a way only a person such as him, who has spent over four decades in the industry, can.

The basis of effective HR auditing lies in asking the right questions

Ronald Adler will emphasize the point that the root to carrying out HR audits effectively is in asking the right questions. The effectiveness of HR audits is measured by how they throw up a structured and systematic series of questions about the areas relating to key compliance, risk management, internal auditing, and human resource management issues in HR, which are the main purpose of these audits.

Key issues affecting HR audits in 2016

Because of the coming together of a variety of factors; HR auditing has taken a new role and importance from 2016. These factors include:

  • The increasing importance of human capital in the age of ever increasing globalization
  • The insufficiency of the present financial institutions to foresee and contain the outbreak of corporate scandals and bring about greater transparency in these institutions
  • The recognition by leading bodies and legislations such as the EEOC, the OFCCP, U.S. DOL, the NLRB, and ICE of the importance of HR audits as an effective tool for self-audits

The role of ERM in HR audits

Another important point that Ronald Adler will highlight at this seminar is the importance of HR audits in considering human capital-related risks and opportunities from an Enterprise Risk Management (ERM) perspective. This means that the HR audit should take a holistic view of human capital risks and align the interrelationships and interactions between HR and other functions relating to management and the organization.

Yet another aspect that will be reviewed is the current use of HR audits. Adler will explain how HR Audits can be used to help the organization reduce risks and grab potential opportunities.

Contact Information:

http://www.globalcompliancepanel.com/

+1-800-447-9407